Nutrition for a companion animal

ABSTRACT

Determining a nutritional diet for a canine or feline companion animal comprises employing a computer; at least one electronic database coupled to the computer; and at least one software routine executing on the computer. First data comprises a relationship between expression data from the genomic map and a physiological condition of the animal, and second data comprises an effect of nutrition on the expression data from the genomic map. Based on said first and second data, a nutritional diet for the canine or feline companion animal is determined.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 12/957,118,filed Nov. 30, 2010, which is a divisional of application Ser. No.12/355,721, filed Jan. 16, 2009, now issued U.S. Pat. No. 7,865,343.This application is also a divisional of application Ser. No.10/635,707, filed Aug. 5, 2003, now issued U.S. Pat. No. 7,548,839,which is a continuation-in-part of and relates to application Ser. No.09/419,192, filed Oct. 15, 1999, now issued U.S. Pat. No. 6,730,023, andalso application Ser. No. 09/432,851, filed Nov. 2, 1999, now issuedU.S. Pat. No. 6,287,254. This application also relates to ProvisionalApplication No. 60/403,203, filed Aug. 12, 2002. The contents of allthose applications are incorporated by reference herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

Not Applicable

THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT

Not Applicable

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPUTER DISC

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

This disclosure is concerned with animal health diagnosis. Moreparticularly, the disclosure is directed to the testing, diagnosis andprediction of diseases and disorders of animal companions, for instancedogs and cats.

Further this disclosure relates to a method, system and apparatus forthe management of comprehensive and cumulative genetic and healthassessment databases in relation to animals worldwide. In particular,the disclosure relates to a bioinformatics system and its implementationin relation to animal biological data.

More specifically the disclosure is directed to animal health care,well-being and nutrition, and methods and systems for enhanceddetermination of these factors.

2. Description of the Related Art Including Information Disclosed Under37 CFR 1.97 and CFR 1.98

General Background

There is a need for a new database management bioinformatics scheme andrelational database, together with computerized networks that manage,analyze, and/or integrate comprehensive and cumulative animal healthassessment data and genetic identifier, genomic mapping, and geneticassessment data. A comprehensive approach to animal health and geneticselection or management of animals, and their clinical care is thesubject of the present disclosure.

Current laboratory and research systems and computerization have notachieved this, nor have communication protocols been used effectively inthis technological area to facilitate such a relationship or relationalbioinformatics database system for management and dissemination of thiscomprehensive and cumulative information.

More specifically, it is necessary in animal health diagnosis and carethat appropriate predictive testing for diseases and disorders ofanimals be achieved in order to reduce morbidity and mortality, andimprove the quality of life and lifespan. Currently this is not done inrelation to the health assessment data of an animal together with thegenetic data related to that same animal. Current tests do not provideas much data as possible to attain correct diagnosis and disorderpredictions with the net result of an improvement in the quality of lifeand increased longevity.

More so, currently available testing is unnecessarily complex andexpensive in relation to the ability to be an accurate predictor ofdiseases and disorders in animals, and hence their likely longevity.

Additionally there is a difficulty of easily obtaining, reading,diagnosing and reporting to clients the diagnosis in a fast andeffective means. Many systems are too complicated and have been premisedon the basis of total automation. There is a need for permitting theeffective human interaction in computerized data for achieving effectivediagnosis, and reporting of that diagnosis in a user-friendly manner.

BRIEF SUMMARY OF THE INVENTION

The disclosure is directed to a method, apparatus and system ofobtaining, analyzing and reporting laboratory test data in relation tothe health assessment data of an animal together with the genetic datarelated to that same animal.

The disclosure also provides a bioinformatics system for inputting,controlling, analyzing and outputting of a broad range of criteriarelated to the health, genetic background and longevity of animals. Thisincludes a system concerning phenotype data and genetic data relating toanimals. Further, there is provided a system for screening of geneticdata and genomic mapping, and integrating the phenotype healthassessment data and genetic identifier and assessment data in acomputerized data processing resource (“CDPR”). Moreover, there isprovided a system for analyzing the health assessment or phenotypic datawith the interrelated genetic or genotypic data. Thereafter, those dataand analyses are communicated from the CDPR in a broad range and in amanner that has not previously been possible.

The present disclosure offers a unique solution to above-describedproblems by providing an apparatus, method and system, in relation toanimals, for performing data analyses of biological specimens fromspecific subject animals or animal groups in relation to specificsubject animal or animal groups of genetic data. The apparatus, methodand system comprises a controller for obtaining, inputting, andanalyzing biological, physiological, and pathological test data togetherwith genomic mapping and genetic screening data into the CDPR.

The biological, physiological, and pathological data of the subjectanimal or animal group and the genetic data of the subject animal oranimal group are communicated to a remote user as raw data or asrelated, analyzed biological, physiological, and pathological data andgenetic data. The remote user can also appropriately access the CDPR toinput data to, or obtain data from, the CDPR.

According to a further aspect of the disclosure there is a dynamicmethod and system of managing the health care and well-being of anon-livestock pet animal subject.

A computer is at least one of an expert system or interrelationshipprogram or network for determining data base and data relationships.This can be a system such as a neural network, or other statisticalsampling systems and networks.

The disclosure also includes the step of reporting the determination ofthe health care, well-being, nutrition or other therapeutic requirementsand suggestions or health on a communications network including theInternet. Preferably, there is a payment procedure for the report whichis achieved through the Internet. This communication network andstructure is described here in further detail.

There is provided means for inputting data into databases, storing thedata in these databases, analyzing the data in a relational sense fromthe different databases, and retrieving the data from these databases,namely the databases which are part of the CDPR.

A further aspect of the disclosure is the accessibility of the healthassessment database and/or genetic database or other databases of theCDPR by the remote user selected on the basis of password, securitycontrol, and financial payment such that the data can be transmittedinto and from the CDPR by a computer network. Use of selected passwords,encryption systems, and payment systems are employed to facilitate andrestrict the flow of data in and/or out of the databases. Alerts can beset up to advise of attempts at unauthorized access to the CDPR. Thecomputer network may conveniently include the Internet.

As required, the data in the CDPR can also be distributed to multipleauthorized remote parties, namely third parties for research or otheranalysis. The disclosure also includes a method and system for achievingthis.

A diagnosis of the health of an animal is obtained through a combinationof computerized data analysis, and human interpretation. Data relates tothe physical characteristics of the animal, and includes data obtainedfrom a physical inspection of the animal. A blood or other fluid sampleis used to obtain a computer generated laboratory analysis. This isreported through an internet network to specialist for analysis by aspecialist clinical pathologist. The clinical pathologist has the datarelating to the physical characteristics, and thereby makes a diagnosisof the animal's overall health status.

A drop-down menu on a computer screen provides supplemental reports tosupport the diagnosis. This supplemental report can be generatedelectronically as determined by criteria pre-selected by a specialistwhich matches the analysis and the data relating to the physicalcharacteristics

This can be enhanced by further input from the specialist pathologistthrough an entry, selectively a keyboard entry, into the computer toobtain an integrated computer report having the laboratory analysis,supplemental report, and selectively, an enhanced report. Oral input toa computer through voice recognition software may be effective indeveloping the enhanced report. The integrated or enhanced report iselectronically or otherwise communicated to a remotely located client.

In one preferred form of the disclosure, the laboratory analyticalreport is reported in a first computer program and the drop down-menu isin a second computer program. The data from the first computer programis transferred to the second computer program.

The electronic communication to the client is selectively by e-mail orfax, and the second computer program includes a utility to transmit theintegrated report from the second program through the utility.

In the system using a drop-own menu, the drop-down menu is contained ina tool bar supplementing an application, selectively a word processingprogram. Computer program applications other than word processingapplications may be the basis for the supplemental report. The tool barincludes icons defining predetermined supplemental reportcharacteristics, and selected icons may be used by the clinicalpathologist to supplement the laboratory analytical report. The iconscan be grouped for animal characteristics dependant on age and sex.Alternatively or additionally, the icons are grouped for animalcharacteristics dependant upon animal grouping. Alternatively oradditionally, the icons are grouped for selected disease states,examples of the states being selectively thyroid disease, behavior,autoimmune disease, and cancer. The icons also can be grouped forselected levels of immunity from infectious disease, that being thetiter of immunity from the disease causing agent (s) in the animal, andtherefore the need for vaccination of the animal against the disease.

The menu, represented by the icons, which define predeterminedsupplemental report characteristics, are selected to be used by theclinical pathologist to supplement the laboratory analytical report,whether the supplemental report is generated automatically by computeror by manual input from the specialist. The menu can be grouped foranimal characteristics dependant on age and sex. Alternatively oradditionally, the menu is grouped for animal characteristics dependanton animal grouping. Alternatively or additionally, the menu is groupedfor selected disease states, examples of the states being selectivelythyroid disease, behavior, autoimmune disease, and cancer. The menu alsocan be grouped for selected levels of immunity from infectious disease,that being the titer of immunity from the disease agent(s) in theanimal, and therefore the need for vaccination of the animal against thedisease.

The data includes a panel of tests related to at least one of endocrinefunction, immunologic function, gastrointestinal function andnutritional analysis, inborn errors of metabolism, paternity, DNAfingerprinting, hemostasis and coagulation function, vaccinal antibodystatus, adverse and potential adverse vaccine reaction, infectiousdiseases, pathology, blood typing and bone marrow analysis, cellcytotoxicity, cytokine and allergy testing, and markers of neoplasticand paraneoplastic change. These data are relevant to the likelymorbidity, likely longevity, and/or the potential risk for disease ordisorder for the animal.

A method and system of obtaining and electronically delivering anassessment of the thyroid function of an animal is achieved through acombination of computerized data and human interpretation related to theanimal. Data relating to the physical characteristics of the animal isobtained, the data being from at least one of a physical inspection ofthe animal, family and breed history, and the data submitted to aclinical pathologist. A blood or other body fluid sample from the animalis submitted for laboratory analysis of the total T4, total T3, free T4,free T3, T3 autoantibody, T4 autoantibody and thyroglobulinautoantibody. Endogenous TSH also can be measured.

A computer generated report of the laboratory analysis is obtained, andreported through a network, selectively an internet network, to aclinical pathologist. The clinical pathologist has the data relating tothe physical, and family and breed history characteristics, and makes afirst assessment off the thyroid function of the animal. From adrop-down menu on a computer screen a supplemental report to support theassessment is generated. This can be selectively enhanced by a furtherinput from the pathologist through data, through entry, selectivelykeyboard entry, into the computer. The assessment is dependant on animalgrouping and/or on animal age and sex.

An integrated computer report having the laboratory analysis,supplemental report, and an selectively enhanced report is communicatedto a remotely located client, such communicating being electronic.

According to a further aspect of the disclosure, data includescharacteristics related to autoimmune thyroiditis of the animal.Biological laboratory test data from a bodily fluid or tissue of ananimal are analyzed. The test data relate to a physiologic or geneticmarker for autoimmune thyroiditis of the animal. The data relates to atleast one of the results of a comprehensive thyroid autoantibody testprofile, DNA fingerprint (the gene map), and markers for immunoglobulinreceptors on B-cells, T-cell receptors, and protein products of themajor histocompatibility complex (MHC) genes (Class I and II allellicHLA, DLA or equivalent antigenic specificities) of the animal. Exampleassays to screen for MHC genes include restriction fragment lengthpolymorphism (RFLP), polymerase chain reaction (PCR) RFLP, PCRsequence-specific oligonucleotides (SSO) and PCR sequence-specificprimers (SSP). The values should fall within predetermined levels as adeterminant of autoimmune thyroiditis.

According to a further aspect of the disclosure, the data includescharacteristics related to the tissue environment of the eye and brain(ocular and blood-brain barrier) which are sites protected from thenormal immunologic surveillance mechanisms. Biological laboratory testdata from a bodily fluid or tissue of an animal are analyzed. The testdata relate to the soluble and cellular immune inflammatory responsemediators (cytokine and chemokine levels, immunoglobulin levels, andlymphycyte susbset markers). The value should fall within predeterminedlevels as a determinant of integrity of protected immune surveillancemechanisms.

According to a further aspect of the disclosure, the data includescharacteristics related to the tendency to bleed excessively aredetermined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to acomprehensive assessment of the hemostatic and coagulation function. Thevalue should fall within predetermined levels as a determinant of thepresence of bleeding disorder.

According to another aspect of the disclosure there is provided a methodand system of obtaining and electronically delivering an assessment ofthe thyroid function of an animal through a combination of computerizeddata and human interpretation related to the animal. Data is obtainedrelating to the physical, and family and breed history characteristicsof the animal, the data being obtained from at least one of a physicalinspection and family and breed history of the animal, or other analysisof the animal. The data is submitted to a clinical pathologist.

A blood or other bodily fluid sample is secured from the animal and issubmitted for laboratory analysis of the total T4, total T3, free T4,free T3, T3 autoantibody, T4 autoantibody and thyroglobulinautoantibody. Endogenous TSH also can be measured. A computer generatedreport of the laboratory analysis; is obtained. The report is related toa selected supplemental database for supplemental analysis, and thesupplemental analysis is related to the data relating to the physicalcharacteristics, and family and breed history. A first assessment of thethyroid function of the animal is possible.

The supplemental report is selectively enhanced by a further input froma pathologist through data, through entry, selectively keyboard entry,into the computer. An integrated computer report having the laboratoryanalysis, supplemental report, and selectively an enhanced report isobtained. This is communicated as the integrated or enhanced report to aremotely located client, such communicating being electronic.

Further aspects of the present disclosure will become apparent in thecourse of the following description and by reference to the attacheddrawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is an overall view of a web-based system to provide access to adatabase management system of an animal genetic database and a healthassessment database of the disclosure, in relation to the Internet.

FIG. 2 is a graphical illustration of a computer network, namely theInternet.

FIG. 3 is a block diagram of an exemplary computer system for practicingvarious aspects of the disclosure.

FIG. 4 is a view of a browser for the database management system foraccessing an animal genetic database and a health assessment database ofthe disclosure.

FIG. 5 is a basic flow diagram illustrating an exemplary process bywhich an operator of a CDPR receives and transmits data relating tohealth assessment and genetic information.

FIG. 6 is a detailed flow diagram of the system steps employed in oneembodiment of the present disclosure wherein a remote user accesses andoutputs data.

FIG. 7 is a detailed flow diagram of the methods and steps employed by aremote user to add data to the database.

FIG. 8 is a laboratory report page from a web site showing the firstlevel of reporting of a patient.

FIG. 9 is an expanded more detailed report of some of the test data ofthe patient shown in FIG. 8.

FIG. 10 is a further elaboration of the test data of FIG. 8 showing adifferent layout in a manner typically used for computer reporting ofthe test data through a web-based system.

FIG. 11 is a print out of the test data report as shown in FIG. 10.

FIG. 12 is a screen view of a word processing program with a blank newpage, and showing a toolbar with icons arranged to represent textrelating to a diagnosis and recommendation.

FIG. 13 is a representative test request submission form relating to thepatient, the submission form containing further data and informationabout the patient.

FIGS. 14A and 14B are representations of the test data report of FIG. 11having super-imposed additional data inserted through the use ofselected icons on the tool bar of FIG. 12, and having added manuallywritten comments.

FIGS. 15A to 15C represent different diagnostic comments represented bythe use of different icons from the toolbar.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure will now be described in detail with reference toa few preferred embodiments thereof, as illustrated in the accompanyingdrawings. In the following description, numerous specific details areset forth in order to provide a thorough understanding of the presentdisclosure. It will be apparent, however, to one skilled in the art,that the present disclosure may be practiced without some or all ofthese specific details. In other instances, well known process stepshave not been described in detail in order to not unnecessarily obscurethe present disclosure.

General

There is provided a method and system of obtaining and electronicallydelivering a diagnosis of the health of an animal through a combinationof computerized data and human interpretation related to the animal.Firstly data relating to the physical characteristics of the animal isobtained. The data is obtained from at least one of a physicalinspection of the animal, and family and breed history, or otheranalysis of the animal. The data is submitted to a clinical pathologist.A blood sample or other bodily fluid sample is obtained from the animal.The sample is submitted for laboratory analysis. A computer generatedreport of the laboratory analysis is obtained. The report is related toa selected supplemental database for supplemental analysis. Thesupplemental analysis is related to the data relating to the physicalcharacteristics, and family and breed history. A diagnosis of the animalhealth is possible. There is then generated a supplemental report tosupport the diagnosis.

The system provides for a computerized network wherein the laboratorysamples are analyzed at a first level and been reported electronicallyto remote clients Superimposed on that first level of reporting there isability to obtain by computerized electronic means to provide thesupplemental analysis. This supplemental analysis can be reportedautomatically to remotely located clients to a computerized orelectronic network. The supplemental analysis can be provided bypreprogrammed criteria provided by different experts in the fieldassociated with the nature of the anticipated illness or anticipateddisease.

In a selected cases wherein the supplemental analysis does not fitpre-selected criteria affecting the disease pattern and the subjectanimal, the report would be directed for manual interpretation by aselected expert in the field. This manual interpretation can be added tothe supplemental report by keyboard input or other voice recognitionsoftware input so that a comprehensive enhanced report can be obtained.This manual interpretation will provide an enhanced report which is thencommunicated electronically to a remotely located client.

Diagnostic Testing

The development of one or more assays or techniques for performing theinvented testing protocols, standards and procedures of the presentdisclosure is straightforward, and within the knowledge of a personskilled in the art. One or more of a panel of tests relate to at leastone of endocrine function, immunologic function, gastrointestinalfunction and nutritional analysis, inborn errors of metabolism,paternity, DNA fingerprinting, hemostasis and coagulation function,vaccinal antibody status, adverse and potential adverse vaccinereaction, infectious diseases, pathology, blood typing and bone marrowanalysis, cell cytotoxicity, cytokines and allergy testing, and markersof neoplastic or paraneoplastic change. These data are relevant to thelikely morbidity, likely longevity, and/or the potential risk fordisease or disorder for the animal.

The following are some examples of diseases, disorders, and physiologicstates that use one or more of the diagnostic test panels set out below:

EXAMPLES Example 1 Temperament and Longevity

Characteristics related to the temperament of the animal which impactson its longevity are determined. Biological laboratory test data from abodily fluid or tissue of an animal are analyzed. Such test data relateto the level of neurotransmitter activity of the animal. The data relateto at least one of the value of serotonin, the gamma-aminobutyric acid(GABA), the glutamate, the dopamine, the glycine, the aspartate, theacetylcholine, the norepinephrine, the histamine, the substance P, thevasopressin, the vasoactive intestinal peptide, the neurotensin, or theother neuropeptides of the animal. The value should fall withinpredetermined levels as a predictive determinant of the animal'stemperament (passivity, assertiveness, or aggressivity).

Methods for measuring neurotransmitters are well known in the art.Neurotransmitters such as serotonin, epinephrine, norepinephrine,glutamate, and GABA can be measured by standard immunochemicaltechniques involving commercially available antibodies, eitherpolyclonal or monoclonal. Such antibodies are commercially availablefrom sources such as Sigma Chemical Company (St. Louis, Mo.). Theseimmunochemical techniques can involve either radioimmunoassay or otherwell-established assay techniques, such as ELISA (enzyme-linkedimmunosorbent assay). These neurotransmitters can also be measured bystandard non-immunochemical techniques such as gas chromatography.Neuropeptide neurotransmitters are preferably measured by immunochemicaltechniques.

Test panels Nos. 1, 2, 3, 8 and 10 set out below can be used to obtaindata for this Example 1.

Example 2 Immune Stimulation and Cellular Inflammatory Response

Characteristics related to at least one of the immune stimulationreaction, evidence of neoplastic or paraneoplastic change, or thecellular inflammatory response of the animal are determined. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relates to at least one of cell cytotoxicitymarkers, cytokine and chemokine levels, immunoglobulin levels, type andamount of lymphocyte subsets and lymphocyte markers, and markers ofneoplastic or paraneoplastic change of the animal. The value should fallwithin predetermined levels as a determinant of the immune stimulationreaction, neoplastic or paraneoplastic change, or the cellularinflammatory response.

Methods for measuring lymphokines and other cytokines are well known inthe art. These compounds are typically measured by immunochemicaltechniques using commercially available monoclonal antibodies or othermethods.

Test panels Nos. 1, 3, 4, 8, 9 and 10 set out below can be used toobtain data for this Example 2.

Example 3 Inherited Organ Dysfunction or Dysplasia

Characteristics related to inherited organ dysfunction or dysplasia ofthe animal, at least one of which is neuronal, neuromuscular or renalare determined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to an amino acid,carbohydrate, lipid or other metabolic component, body fluid or tissuemarker of the animal. The data includes obtaining data related to atleast one of the value of the methyl malonic acid, the fucose-containingcell metabolites, blood or urine urate or uric acid metabolites,normoglycemic glycosuria, mannosidase containing cell metabolites, aminoacid uria, amyloid deposition in tissues, neuronal ceroid lipofuscindeposition, and deposition of gangliosides and other lysomal storagesubstrates of the animal. The value should fall within predeterminedlevels as a determinant of the inherited organ dysfunction or dysplasia.

Test panels Nos. 1, 3, 5, 9 and 10 set out below can be used to obtaindata for this Example 3.

Example 4 Autoimmune Thyroiditis

Characteristics related to autoimmune thyroiditis of the animal aredetermined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to a geneticmarker for automimmune thyroiditis of the animal. The data relates to atleast one of the results of a comprehensive thyroid antibody testprofile, DNA fingerprint (the gene map), and markers for immunoglobulinreceptors on B-cells, T-cell receptors, and protein products of themajor histocompatibility complex (MHC) genes (Class I and II allellicHLA, DLA or equivalent antigenic specificities of the animal. Testassays to screen for MHC genes include restriction fragment lengthpolymorphism (RFLP), polymerase chain reaction (PCR) RFLP, PCRsequence-specific oligonucleotides (SSO) and PCR sequence-specificprimers (SSP). The value(s) should fall within predetermined levels as adeterminant of autoimmune thyroiditis.

Test panels Nos. 1, 2, 3 and 10 set out below can be used to obtain datafor this Example 4.

Example 5 Mammary Cancer

Characteristics related to presence of or susceptibilty to mammarycancer of the animal are determined. Biological laboratory test datafrom a bodily fluid or tissue of an animal are analyzed. The test datarelate to estrogen (estradiol-17β), estrogen receptors, interleukin (IL)6, progesterone, and progesterone receptors. The value should fallwithin predetermined levels as a determinant of the presence of orsusceptibilty to mammary cancer.

Test panels Nos. 1, 2, 3 and 10 set out below can be used to obtain datafor this Example 5.

Example 6 Immune Surveillance

Characteristics related to the tissue environment of the eye and brain(ocular and blood-brain barrier) which are sites protected from thenormal immunologic surveillance mechanisms are determined. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relate to the soluble and cellular immuneinflammatory response mediators (cytokine and chemokine levels,immunoglobulin levels, and lymphycyte susbset markers). The value shouldfall within predetermined levels as a determinant of integrity ofprotected immune surveillance mechanisms.

Test panels Nos. 1, 3, 5, 6, 8, 9 and 10 set out below can be used toobtain data for this Example 6.

Example 7 Inherited Bleeding Disorders

Characteristics related to the tendency to bleed excessively aredetermined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to acomprehensive assessment of the hemostatic and coagulation function. Thevalue should fall within predetermined levels as a determinant of thepresence of bleeding disorder.

Test panels Nos. 1, 7, and 9 set out below can be used to obtain datafor this Example 7.

Test Panels

The following are some specific diagnostic test panels and specializeddiagnostic tests and test groups used to monitor health, morbidity,mortality and longevity of animals and animal families, and to predictthe potential risks of disease or disorder:

Test 1: Comprehensive Diagnostic Test Panel

Patient phenotypic descriptors and genotypic descriptors/background;complete blood count (CBC) and platelet count, platelet size, plateletmorphology; serum chemistry profile [e.g., AST (SGOT), ALT (SGOT),bilirubin (total, direct and indirect), alkaline phosphatase, GGT(GGTP), total protein, albumin, globulin, A/G ratio, cholesterol, BUN,creatinine, BUN/creatinine ratio, phosphorus, calcium, correctedcalcium, calcium/phosphorus ratio, glucose, amylase, lipase, sodium,potassium, Na/K ratio, chloride, CPK, triglyceride, osmolality];complete thyroid profile (total T4, total T3, free T4 (ED or other),free T3, T3 autoantibody, T4 autoantibody, TSH, thyroglobulinautoantibody); and urinalysis, urine culture, and sensitivity, ifindicated.

Test 2: Diagnostic Test Panels for Endocrine Function

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all of selected tests from the following list:

1) Thyroid Function: total T4, total T3, free T4 (ED or other), free T3,T3 autoantibody, T4 autoantibody and thyroglobulin autoantibody.Endogenous TSH also can be measured. Molecular screening for autoimmunethyroiditis including immunoglobulin receptors on B-cells, T-cellreceptors, and major histocompatibilty complex (MHC) genes Class I andII allellic HLA, DLA, or equivalent animal antigenic specificities(RFLP, PCR/SSO, PCR/SSP).

2) Adrenal Function: cortisol (basal and after stimulation with ACTH, orserially after suppression with high or low-dose dexamethazone);endogenous cortisol; and endogenous ACTH.

3) Reproductive Function: testosterone; estradiol-1713; relaxin(pregnancy diagnosis); progesterone; luteinizing hormone; estronesulfate; follicle stimulating hormone; vaginal cytology and/or culture;testicular cytology or biopsy; prostatic cytology, biopsy or wash;screens for ovarian or testicular remnants.

4) Pancreatic Function: amylase; lipase; glucose; glucagon, trypsin-likeimmunoreactivity (TLI); insulin, fructosamine; glycosylated hemoglobin.

5) Parathyroid Hormone Function: parathormone; ionized calcium.

6) Other Endocrine Function: aldosterone; 21 adrenal hydroxylase;vanylla mandelic acid (VMA, for epinephrine and norepinephrinemetabolities).

Test 3: Diagnostic Test Panels for Immunologic Function

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all of selected tests from the following list:

Antinuclear antibody (ANA)—if positive, run double stranded, singlestranded, speckled, anti-RNA levels; Coombs' testing (direct andindirect; elution or microbeads gel-test); rheumatoid factor; serumelectrophoresis—if abnormal, run immunoelectrophoresis, isoelectricfocusing, immunoblotting (Western, Northern, Southern blots);immunoglobulin levels (IgG, IgA, IgM, IgD and IgE); complement levels(C1, C1a, C1 esterase inhibitor, C3, C4, C5-C9); LE-prep testing; lupusanticoagulant (dilute Russell's viper venom test or dilutional inhibitortest); urine protein SDS-gel electrophoresis; fibronectin andanti-fibronectin antibody; flow cytometry with fluorescence activatedcell sorter (FACS, for leukocyte subsets and markers such as CD4+ andCD8+; leukocyte chemotaxis (leukocyte migration inhibition test,leukotrienes); cytokines including lymphokines and monokines(macrophage-derived) such as the interleukins (IL) [e.g. IL-6 regulatedby estradiol-17β, IL-8 acts as neutrophil chemotactic factor],interferons, tumor necrosis factor(s), leukotrienes, colony stimulatingfactors, transforming growth factor-beta and chemokines (inflammatorycytokines); anti-platelet antibody tests (serum, bone marrow);anti-megakaryocyte antibody tests (IFA, elution); and anti-leukocyteantibody tests (direct and indirect anti-neutrophil cytoplasmicantibody, antilymphocyte antibody, etc.).

Test 4: Diagnostic Test Panels for Gastrointestinal Function andNutritional Analysis

Patient phenotypic descriptors and genotypic descriptors/background,plus nutritional and food supplement past and current use, plus any orall of selected tests from the following list:

Serum nutrients and vitamin analysis; CBC as in Test 1; serum chemistryas in Test 1 plus magnesium and iron; urinalysis, urine culture andsensitivity, if indicated; urine fractional excretion; serum and urineamino acid analyses; serum cobalamin (vitamin B12) and folate analysis;TLI [same as Test 2, 4)]; fecal flotation; Giardia screen, Clostridiumperfringens enterotoxin test; cryptosporidiosis test (FA); toxoplasmosistest; bile acids test (resting and post-prandial); fecal alpha-1protease inhibitor activity. If any abnormalities are present, furtherinvestigation includes ion-coupled plasma emission spectroscopy (ICP)for mineral analysis, and electrophoresis.

Test 5: Diagnostic Test Panels for Inborn Errors of Metabolism

Characteristics related to presence of or susceptibilty to mammarycancer of the animal are determined. Biological laboratory test datafrom a bodily fluid or tissue of an animal are analyzed. The test datarelate to estrogen (estradiol-17β), estrogen receptors, interleukin (IL)6, progesterone, and progesterone receptors. The value should fallwithin predetermined levels as a determinant of presence orsusceptibilty to mammary cancer.

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Genetic screening tests including blood and urine analyses formucopolysaccharides, cerebrosides, glycogen-storage diseases,phenylketones, phosphofructokinase, mannosidases, combined and specificimmunoglobulin deficiencies/dysfunctions; skin and tissue biopsies;karyotyping for genotype determination; and DNA marker analyses.

Test 6: Diagnostic Test Panels for Paternity Testing and DNAFingerprinting

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Major histocompatibilty complex (MHC) Class I and II alleles [analysesof HLA, DLA, or equivalent animal antigenic specificities]; genotyping;gene mapping and fingerprinting.

Test 7: Diagnostic Test Panels for Hemostatic and Coagulation Function

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Platelet count, platelet size (blood slide, mean platelet volume),platelet morphology (light, scanning, and electron microscopy);prothrombin time; partial thromboplastin time; fibrinogen;fibrin-fibrinogen degradation products (D-dimer test); platelet functiontests (aggregation, release, clot retraction, whole blood aggregation,ristocetin cofactor); von Willebrand factor antigen and multimeranalysis; specific coagulation factor analyses (factors II, V, VII,VIII:C, IX, X, XI, XII, XIII); fibrinolytic tests (plasminogen, plasmin,antiplasmin, tissue plasminogen activator, dilute whole blood lysistest, euglobulin lysis test); anti-thrombin III test; circulatinganticoagulant tests; platelet factors 3 and 4 (heparin cofactor);protein C; protein S; kinin-kinogen tests; prekallikrein test;alpha1-antitrypsin assay; alpha2-macroglobulin assay; C1 esteraseinactivator assay; anti-platelet antibody, and anti-megakaryocyteantibody tests (see Test 3).

Test 8: Diagnostic Test Panels for Vaccinal Antibody Status, and AdverseVaccine or Potential Adverse Vaccine Reaction

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

1) Serology for Vaccinal Antibody: canine distemper, canine parvovirus,canine coronavirus, canine parainfluenza virus, infectious caninehepatitis virus, canine Bordetella, canine Lyme (borrelia), canineleptospirosis, rabies virus, feline panleukopenia virus, feline leukemiavirus, feline infectious peritonitis virus, feline immunodeficiencyvirus, feline calicivirus, feline herpesvirus, and equine herpes viruses(I-IV), etc.

2) Adverse Vaccine Reaction: Same as Test 3, but especially CBC; ANA;Coombs' test; platelet count, size, and morphology; anti-neutrophilcytoplasmic antibody, marker for vasculitis; complement tests; leukocytechemotaxis tests; urine protein/creatinine ratio; anti-plateletantibody; immunoglobulin levels, especially IgG, IgA, IgM; flowcytometry (FACS) leukocyte subsets; cell cytotoxicity analysis;cytokines, especially chemokines; and complete thyroid autoantibodypanel.

3) Potential (High Risk) Vaccine Reaction: especially for breeds such asthe Akita, Weimaraner, Standard poodle, Eskimo Dog, harlequin GreatDane; CBC; ANA; platelet count, size and morphology; complete thyroidautoantibody panel; cell cytotoxicity analysis; cytokines; andimmunoglobulin levels, especially IgG, IgA, IgM;

Test 9: Diagnostic Test Panels for Infectious Diseases

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

1) North America: Ehrlichia species (E. canis, E. risticii, E. equi, E.platys, etc.); Rickettsia rickettsei (RMSF); Borrelia species (Lymedisease); Bartonella species (B. henselae, B. vinsonii, B. clarridgeiae,B. kochlerae); systemic fungal diseases (Coccidioides spp, Cryptococcusspp, Histoplasma spp, Blastomyces spp, Aspergillus spp, ringworm); mangemites (Demodex, Sarcoptes, Chyletiella, etc.); enteric diseases(Clostridium perfringens enterotoxin); protozoan diseases (Toxoplasmaspp.; Coccidia spp; Giardia spp); retrovirses (feline leukemia virus,feline immunodeficiency virus, equine infectious anemia virus, bovineleukemia virus, caprine arthritis virus; Corona viruses (caninecoronavirus, feline enteric coronavirus, feline infectious peritonitisvirus; Babesia spp (B. canis, B. gibsoni); Dirofilaria spp (heartworm);other parasitic diseases (fleas, ticks, roundworms, tapeworms,hookworms, Strongyles and other intestinal parasites); and Chlamydiaantigen (PCR testing).

2) International: Same as above plus Leishmania spp; Trypanosoma spp.;Anaplasma spp; Yersina pestis.

Test 10: Other Diagnostic Tests

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Pathology (anatomic, histological, cytologic, immunohistochemical,electromicroscopy, FACS); blood typing; bone marrow analysis andspecific immunohistochemical staining; RFLP and PCR testing (applicableto many of the above categories); IFA and FA testing; ELISA testing,cell cytotoxicity testing, cytokine testing (see Test 3, other cytotoxiccell and mitochondrial tests); markers of neoplastic and paraneoplasticchange (cancer); neurotransmitters including serotonin, thegamma-aminobutyric acid (GABA), the glutamate, the dopamine, theglycine, the aspartate, the acetylcholine, the norepinephrine, thehistamine, the substance P, the vasopressin, the vasoactive intestinalpeptide, the neurotensin, or the other neuropeptides; and amino acidprofiling.

Data for Animal Health

The health care and well-being could include the nutritional managementor the health management or the lifestyle management. The data base ofthe selected group of the species is at least one of breed, age, sex,size, weight, performance use, or geographical location.

The nutritional regimen is at least related to the nutrient or caloriccomposition needed for the dog subject, or the food allergies and foodintolerances of the dog subject. The therapeutic intervention ormaintenance needs of the dog are at least one of drugs, nutraceuticals,liquid intake, holistic treatments or exercise.

The diagnostic laboratory test data is a comprehensive general healthprofile and selectively at least one selected diagnostic profile for aselected subject. The laboratory data for the subject is ideallyobtained over time from the same laboratory. This is likely to enhancethe uniformity of the data, and render the determinations more accurate,and predictive of health, nutritional requirements, temperament, andlongevity.

Enhanced health care and well-being management of the dog subject isobtained. Thus the data of the dog subject is compared to substantiallyor essentially current data. Similarly, by retaining a historical recordof the dog subject data and relating this to the updated databases, theaccuracy with which the management of the health care and well-being,and the development and design of nutritional requirements ortherapeutic and maintenance interventions is significantly enhanced. Inthis manner, for instance the food, supplements, nutraceuticals and thelike, can be modified by additions and/or subtractions of componentsbased on the determined relationship, since these cumulative and dynamicdata bases and data analytes change over time, whereby the determinedrelationship is significantly enhanced

The computer program can include at least one of an expert system orinterrelationship program or network for determining data base and datarelationships. This can be a system such as a neural network, or otherstatistical sampling systems and networks, and is discussed in moredetail.

The determination of the health care, well-being, nutritional or othertherapeutic requirements and suggestions for promoting and maintaininghealth of the dog is reported on a communications network including theInternet. There is a payment procedure for the report which is achievedthrough the Internet. This is discussed in more detail.

An example of the comprehensive diagnostic testing used in thisdisclosure is shown by the test panels in the application labeled as“Test 1: Comprehensive Diagnostic Test Panel”, and then there areselected examples for diagnostic panels that look at specific organfunctions, such as endocrine function, immunological function,gastrointestinal function and nutritional analysis, and inborn errors ofmetabolism. A specific example could be the diagnostic test panel forthyroid function which depends upon the comprehensive diagnostic testpanel and then more specific tests focused on the thyroid, includingmolecular-based testing and genomic mapping.

The term “group” here has many different characteristics. It couldinclude, for example, a specific breed of canine, a specific purpose forwhich these canines are used, such as those who are purely companionpets in a home situation, performance animals for show conformation, forobedience, working trials, coursing trials, and for sheep herding andother herding purposes. It could also involve groups of animalsdepending on where they live—in a temperate climate, a warm or tropicalclimate, an arid desert climate, or a cold northern climate. It willinclude, of course, animals that live in urban and rural areas, animalsthat live near water, animals of various ages, intact or neutered sex,and for reproduction. In other words, the term “group” is used in a verybroad sense here and can apply to any group that the user wishes toinquire of the database. Thus, the group is any selected subset of thehealthy or diseased or disordered animals within the entire database.

The determination of the interrelationships between individuals orgroups of individuals in the database can use any one of a number ofcomputerized or other methods of analysis, simple or complex, includingsuch things as neural networking or other kinds of relational technologyevaluative databases.

Overall System

FIG. 1 is an overview of the web-based system to provide access to theinvented database management system. With this system multiple users,for instance, remote users 8, access the web site 4 using the Internet6. Each of the users 8 has a computer terminal with the appropriatesoftware for accessing Internet. The users 8 may be unknown to the webserver computers 10 and 12. Each user 8 is allowed to browse the website and explore how the system functions.

There are several aspects to maintain security of information maintainedin the database server 22 and a banking system 28. A firewall 20prevents any user 8 from accessing any of the components behind thefirewall 20. In this way the users 8 have access to the web servercomputers 10 and 12, but only have access to the database server 22through the firewall 20. The database server 22 maintains, among otherthings, various database fields with respect to each of the healthprofiles of subjects and the genetic information of a subject andgroups. The database 22 maintains the services with a designationassociated to determine what health assessment data and genetic data canbe browsed by the users 8. Each of the web server computers 10 and 12allow users 8 to view subject and group categories and actual servicesand data products which are available from the database.

The web server computers 10 and 12 can be identical and can beduplicated as additional load or growth on the system occurs. The webserver computers 10 and 12 share the responsibility for servicing theusers of the site. This arrangement provides for expandability of thesystem by merely adding additional web server computers as necessary.

Preferably, the system includes an appropriate computer terminal 24 forinterfacing with independent financial institutions which are connectedon-line via the serial connection 26 to the financial institutioncomputers 28. This allows automatic real time confirmation of the accessof health profile and genetic data services and products. Once a userrequires access to a product or service, the user goes through anidentification or registration process and the exchange of financialinformation to allow for credit or debit card payment of the purchase.This is verified, confirmed and authorized by the appropriate banksystem institution 28. Confirmation of the purchase or deposit of data,or a service is made by a mail server 34 which sends an E-mail to theuser 8 confirming the purchase or deposit. The mail server 34 allows formail to be received and sent out. Security of the various databases ismaintained. Alert messages are generated when an unauthorized access isattempted. Verification messages, authorization messages andconfirmation messages are generated as appropriate.

The database server 22 is also designed to interact with an inputcomputer 32 operated by a CDPR. A firewall 30 serves to preventunauthorized access to the database server 22 or to the input computer32. The input computer 32 can input health profile data and genetic datato the database, after appropriate access and/or passwords are enteredinto the system. Similarly, users 8 through their own computers can useappropriate access codes and passwords to access input data to thedatabase server 22. This is tightly controlled for security reasons. Thedata may only be added to an independent sub-database of the data server22, and only after scrutiny by the CDPR operator of the database throughinput computer 32, will this data from users 8 be subsequently added tothe main database server 22.

FIG. 2 is an illustration of the Internet and its use in the system ofthe disclosure. The Internet 6 is a network of millions ofinterconnected computers 40 including systems owned by Internetproviders 42 and information systems 44 such as America Online™.Individual or corporate users may establish connections to the Internetin several ways. A user on a home PC 46 may purchase an account throughthe Internet provider 42. Using a modem 48, the PC user can dial up theInternet provider to connect to a high speed modem 50 which, in turn,provides a full service connection to the Internet. A user 52 may alsomake a somewhat limited connection to the Internet through a system 20that provides an Internet gateway connection 54 and 56 to its customers.The database 22 is also connected into the Internet 6 through anappropriate modem or high speed or direct interface 58. The database 22is operable and maintained by the CDPR operator computer 60. Users ofthe databases of the disclosure would access the Internet in anappropriately selected manner.

FIG. 3 is a block diagram of an exemplary computer system 100 forpracticing various aspects of the disclosure. The computer system 100includes a display screen or monitor 104, a printer 106, a disk drive108, a hard disk drive 110, a network interface 112, and a keyboard 114.The computer system 100 includes a microprocessor 116, a memory bus 118,random access memory (RAM) 129, read only memory (ROM) 122, a peripheralbus 124, and a keyboard controller 126. The computer system 100 can be apersonal computer, such as an Apple computer, e.g., an Apple Macintosh™,an IBM™ personal computer, or a compatible, a workstation computer, suchas a Sun Microsystems™ or Hewlett-Packard™ workstation, or some othertype of computer.

Microprocessor 116 is a general purpose digital processor which controlsthe operation of computer system 100. Microprocessor 116 can be asingle-chip processor or can be implemented with multiple components.Using instructions retrieve from memory, the microprocessor 116 controlsthe reception and manipulation of input data and the output and displayof data on output devices.

Memory bus 188 is used by the microprocessor 116 to access RAM 120 andROM 122. RAM 129 is used by microprocessor 116 as a general storage areaand as scratch-pad memory, and can also be used to store input data andprocessed data. ROM 122 can be used to store instructions or programcode followed by microprocessor 116 as well as other data.

Peripheral bus 124 is used to access the input, output, and storagedevices used by computer system 10. These devices include the displayscreen 104, printer device 106, disk drive 108, hard disk drive 110, andnetwork interface 112. The keyboard controller 126 is used to receiveinput from the keyboard 114 and send decoded symbols for each pressedkey to microprocessor 116 over bus 128.

The display screen or monitor 104 is an output device that displaysimages of data provided by microprocessor 116 via peripheral bus 124 orprovided by other components in computer system 100. The printer device106 when operating as a printer provides an image on a sheet of paper ora similar surface. Other output devices such as a plotter, typesetter,etc. can be used in place of, or in addition to the printer device 106.

The disk drive 108 and hard disk drive 110 can be used to store varioustypes of data. The disk drive 108 facilitates transporting such data toother computer systems, and hard disk drive 110 permits fast access tolarge amounts of stored data.

Microprocessor 116 together with an operating system operate to executecomputer code and produce and use data. The computer code and data mayreside on RAM 120, ROM 122, or hard disk drive 120. The computer codeand data could also reside on a removable program medium and loaded orinstalled onto computer system 100 when needed. Removable programmediums include, for example, CD-ROM, PC-CARD, floppy disk and magnetictape.

The network interface circuit 112 is used to send and receive data overa network connected to other computer systems. An interface card orsimilar device and appropriate software implemented by microprocessor116 can be used to connect computer system 100 to an existing networkand transfer data according to standard protocols. As such he computersystem is connectable through an interface device with the Internet 6.

Keyboard 114 is used by a user to input commands and other instructionsto computer system 100. Other types of user input devices can also beused in conjunction with the present disclosure. For example, pointingdevices such as a computer mouse, a track ball, a stylus, or a tabletcan be used to manipulate a pointer on a screen of a general-purposecomputer.

The present disclosure in relation to the animal database management ofdata can also be embodied as computer readable code on a computerreadable medium. The computer readable medium is any data storage devicethat can store data which can be thereafter read by a computer system.Examples of the computer readable medium include read-only memory,random-access memory, magnetic data storage devices such as diskettes,and optical data storage devices such as CD-ROMs. The computer readablemedium can also be distributed over network coupled computer systems sothat the computer readable code is stored and executed in a distributedfashion.

Specific System

FIG. 4 illustrates a browser system for use with the database system ofthe disclosure. A browser goes through a number of preliminary screensand logic steps, and reaches a screen 60 entitled “Next Entry”. Thisscreen provides data details or information generally indicated as 62.Clicking on any of these categories allows the user to review databasedetails 64, data specific details as generally indicated by 66. In thisway, the user can index through a number of screens to get informationregarding the different databases of the system. In addition, clickingon any of the triggers 70, 72, 74 and 76 is possible. These correspondto HOW IT WORKS, SECURITY, EXTENDED DATA and PRE-REGISTRATION. Clickingon trigger 70 provides the user with information on how the processworks, explains the system, and provides details on how the user canparticipate in the database and obtain data or input data. Clicking ontrigger 72 provides details regarding security of the system andautomatic payment. In some cases, products and services are offered withextended data and clicking on trigger 74 which can provide details ofthe extended data and explains that this may only be available oncertain services or products.

Trigger 76 allows a user to pre-register and obtain user ID number. ThisID number is combined with financial information retained in thedatabase in an encrypted form. The pre-registration trigger 76 followswith step 78 which is to gather personal information such as credit cardnumber and expiry date to allow for automatic payment. Step 80 is tovalidate a current existence in the database, if this occurs. With anegative answer, the user is directed into a registration processindicate as 82. A user ID is assigned and a password is entered. Thisinformation is maintained in a portion of the database 22. At 84 theuser is provided a screen identifying the user ID at screen 86. If theuser already exists, the registration process is rejected at 88 and theuser is advised of the information at the display 86. The screen at 86would also represent the information which is available in the database22.

In FIG. 5 there is shown a basic block diagram of the components makingup the CDPR. There is the phenotype database or physical health database200 and a genotype database or genetic information database 201. Theseare contained in part of the overall CDPR database 202. User input 203can be obtained from a remote user such as a veterinarian, owner,breeder, or the operator of the database, an agent or researcher. Theoutput from the database 204 could be to the veterinarian, owner,breeder, operator, agent or researcher.

FIG. 6 shows a relationship for retrieving data from the database 202.The user 8 is represented here as a veterinarian, owner, breeder,operator, or researcher 203 who accesses the CDPR 202 accesses a firstscreen through a computer network 6 which inquires about informationabout the user. An access request message is sent, and an appropriateaccess enabling message is transmitted. The user 203 can obtain partialor full access to the CDPR 202 according to the scale of authority givento the user 203 to access data. There is a computer program system 205to ensure that payment is made as appropriate before access to the CDPR202 is granted. In some situations, the appropriate access code 204 canpermit bypassing the payment requirement 205 as indicated by line 206.Payments 205 through the computer program can be effected by a creditcard entry and automatic transfer to a financial institution on behalfof the operator of the CDPR 202. Such payment for access to the databaseis effected by a system which is well known in the art. The financialinstitution will appropriately credit the operator of the CDPR 202 in afinancial manner as established between the operator and the financialinstitution.

Within the CDPR 201 there is the ability to access the physical healthphenotype database 200, the genotype database 201, and other databases207, 208 and 209, respectively. The phenotypic and genotypic informationtogether with other database information can be presented on a singlescreen or monitor or other viewing means, for instance, hard copyformat. The access therefore can be to multiple databases containedwithin the CDPR 202. After accessing the physical health database 200,the user obtains an analysis report from module 210. The user is thenable to read the analysis as indicated by 211 and output the analysisfrom the read-out 211 as indicated by output 212. The output 212 can bea computer screen read-out, fax or voice information.

The physical health or phenotype database 200 is subject or groupspecific. In other words, the data obtained in that database is specificto a particular animal or animal group (breed, family, species, etc.)which has been the subject of a laboratory or research biologicalexamination such that fluid or tissue samples have been subject toanalysis in one or more laboratory or research environments. Thesebiological reports can include those from specimens of blood, urine,other body fluids, skin, eyes, skeletal and other tissues. The PTdatabase 200 has the ability to store the subject specific informationas required within the CDPR 202.

The genotype specific or genetic disorder or disease data is retained inthe database 201 within the CDPR database 202. This data is eithersubject specific, family specific, breed specific, species specific,disorder specific, or disease specific, and is group or subjectspecific. The user can access the genotype database 201 and obtain aread-out 213 which can then be transmitted along line 214 to an output212 in the same manner that the physical health assessment is obtainedas an output.

In an alternative approach, the reader can request an analysis 215 fromthe genotype database as indicated by line 216. This analysis canreceive data along line 217 from the analysis information of thephysical health assessment. Interpretation of the PT and GT can beobtained as indicated by 218, and this can then be outputted asindicated along line 219. The interpretation of PT and GT 218 can beperformed by an algorithm relating to the coefficients andpredictability of information relating to disorders, disease andlongevity when considering the data from the two databases PT 200 and GT201. This can be done automatically and outputted along line 219, orthere can be an expert interface 220 using skilled personnel tointerpret the data of block 218, and this can, in turn, be outputtedalong line 221 to the output 212.

Database 207 can be a genetic marker database, and the information fromthat database can be directly input into the output through a read-out222 and 223 to the output 212. Alternatively, the data from database 207can be added to the interpretation section 218 of the physical healthand genetic information by directing the data along line 224. This datacan then be made the subject of the output along the line 219 and 221 asrequired.

Similarly other databases 208, 209, respectively, have read-outs 225 and226 which can be directly coupled along lines 227 and 228 to the output,or can be directed optionally along lines 229 and 230 to theinterpretation module 218. It can then be the subject of interpretationfor an expert interface 220 review which is, in turn, made the subjectof the output 219 and 221.

In each of the output lines 219, 221, 222, 223, 227, 228, and 214 thereis also provided an encryption program 231 which can be optionally usedin the system. The output 212 can include paper, electronic, or voiceread-out as is required.

In this manner, the output 212 provides a compilation which combines thephysical health and genetic information relating to a subject, thebreed, disease, disorder and lifespan, thereby enabling the receiver ofthe output 212 to use the compiled information in a manner to facilitatebreeding criteria which can be important in relation to animals whichare usually inbred or line bred. The information can also be used tofacilitate on-going monitoring of particular subject animals. The datafrom this system can be used to manipulate and regulate breeding,health, and longevity effectively among animals.

The system of the disclosure is further described with regard to FIG. 7which is a system for inputting data to the CDPR 202. Here multipleusers 203, which can be a remote user such as a laboratory, a breeder,an owner, hospital, agent, or an operator of the CDPR 202 accesses thesystem through module 204 which, in turn, accesses the CDPR 202.Appropriate access request and access enable messages are sent. Withinthe CDPR 202 there is a physical health or phenotype module 200, agenetic or genotype data module 201, and other database modules 207,etc. After accessing the CDPR 202, additional data can be added to themodules 200, 201, 207, etc. through any of the users 203, if authorized.Depositing data into each of the modules 200, 201 and 207 can optionallyrequire the payment to the operator of the CDPR 202 as is indicated byblock 205. This system can function in the same manner as the retrievalof data from CDPR 202.

The stored data in each of the blocks 200, 201, and 207 can be set up asindicated by block 232 in a manner which is restricted or unrestrictedto selected users 203. This may be necessary according to the protocolsgoverning the inputted data to the different databases. In some cases,the waiving of deposit fees is made in the interest of freedom of thedatabase to subsequent users who wish to retrieve data from thedatabase. After storage of the data as indicated by block 234, the user203 exits CDPR 202 as indicated by block 233.

As is apparent, the physical health or phenotype profile of subjectanimals is dynamic and grows as more data is added into the system.Likewise, the genetic genotype database also grows as increasingresearch of particular subjects, breeds, and the like is obtained. Thedeposit of new information into the CDPR 202 is regulated in a mannerthat the data cannot distort the databases 202 in an in appropriatemanner. Likewise, users 203 cannot access the secured databases withinCDPR 202 in an inappropriate manner.

Different algorithms regulate the relationship between the healthprofile, the genetic data, and other data relating to animals. Thesealgorithms determine the probabilities, possibilities, and likelihood ofdisorders and disease in subject animals and offspring animals. They areused as predictors of the future evolvement of health of the animal.

Analyzing the data from the CDPR 102 in the manner of the presentdisclosure permits for genetic screening, health assessment profiling,and the diagnostic, prophylactic, and therapeutic management of animals.

An exemplary server performs all the operations of a conventionaldatabase system and performs additional operations in accordance withthe present disclosure as has been discussed. The server includes acentral processing unit (CPU) together with associated memory forprocessing information about different animals species and history. Theinquiries concern animals species and history and inquiries and requestsfor health profiling and genetic information, and providing healthprofiles and genetic information. The CPU is coupled to the database andto users via a communications port. The CPU is also coupled to anelectronic mail processor for processing and storing (in a storagedevice) e-mail messages transmitted between the CPU and various agents,users and the like. The CPU is further coupled to a data storage device.A data storage device may include a variety of the databases. The systempermits for the requesting, storing and providing of data with respectto animal phenotypic information and genetic information. The format andcontent of the databases have been discussed in detail.

In one form of the disclosure, the desired data is based on thesubmission of test specimens of a specific animal to the laboratory. Insome other cases health profile test data 200 can be inputted into theCDPR 202 having the genetic database 201. The CDPR 202 can perform ananalysis and correlation between the health profile database 200 and thegenetic database 201.

Using the communications link, the remote user 8 communicates with thelaboratory or the CDPR 202. Specimens can be packaged and physicallytransported to the laboratory site via commercially available commoncarriers, such as the postal service or courier services. When thepackages arrive, the laboratory places them in storage, or the tests areperformed. Instruments 300 perform the tests to obtain data as specifiedby the remote user 8. The biohazardous samples can be disposed of awaste material. The test results, or output is provided as part of ahealth profile database 200 of the CDPR 202 and is available to theremote user 8.

If desired, the remote user 8 can arrange to have the data stored in theCDPR 202, made available to other remote users 8. The remote user 8 canalso request the laboratory to perform analysis on the health profiledata 200 generated.

In one embodiment, the communications link is a computer network and themessage transfer modality is, for instance, the Internet 6, and/or anIntranet and/or an Extranet. The network systems are particularly suitedto the application described herein since it offers global or widespreadaccessibility and high speed data transfer of large amounts ofinformation.

A security unit allows remote users to designate who has permission toview or use their data. Feasible options for these informationmanagement requirements include: access by the submitting remote usersonly, access by certain designated researchers and collaborators,time-embargoed data followed by wider access, and unrestricted access byall. A commerce unit can implement functions related to the businessaspects of the CDPR facility, including billing, inventory management ofsupport materials.

A multimedia unit comprises means to store, manipulate, and presentaudio, graphical, video information. This information may include avideo explaining how the CDPR is used, a visual depiction of the data,methodology, or a comment regarding the background of the data. Themultimedia unit may also implement subscription functions, so thatupdated data automatically provided to remote users or other interestedparties.

The operations performed by the present disclosure begins when thecontroller receives an access request message from the remote user via acommunication link. Using information in the access request message andany other available information, the controller determines if the remoteuser is authorized to access the CDPR 202. If so, an access enablingmessage is transmitted from the controller to the remote user 8. Theaccess enabling message can comprise a set of computer instructionstransmitted over the Internet 6 which is downloaded into the remote usermemory for execution by the remote user processor. These instructionsmay be enabling, that is, they may allow direct communication betweenthe remote user 8 and the CDPR 202 with no further need for thecontroller. In another embodiment, the access enabling message maysimply comprise a password or other enabling message which allows theremote user 8 to proceed. The remote user 8 can access or submit data tothe CDPR 202 according to different protocols and regimes and securityarrangements.

FIG. 8 shows a typical laboratory report page from a web site showingthe first level of reporting of a patient. FIG. 9 shows an expanded moredetailed report of some of the test data of the patient shown in FIG. 8.A further elaboration is shown in FIG. 10. There is a different layoutof the data, namely in a manner typically used for computer reporting ofthe test data through a web-based system. FIG. 11 shows the print out ofthe test data report as shown in FIG. 10.

FIG. 12 is a screen view of a word processing program with a blank newpage, and showing a toolbar with icons arranged to represent textrelating to a diagnosis and recommendation. This is part of a drop downmenu. FIGS. 14A and 14B are representations of the test data report ofFIG. 11 having super-imposed additional data inserted through the use ofselected icons on the tool bar of FIG. 12, and having added manuallywritten comments. FIGS. 15A to 15C represent different diagnosticcomments represented by the use of different icons from the toolbar.

A diagnosis of the health of an animal is obtained through a combinationof computerized data and human interpretation. Data relates to thephysical characteristics of the animal, and includes data obtained froma physical inspection of the animal. A blood or other fluid sample isused to obtain a computer generated laboratory analysis. This isreported through an internet network to the clinical pathologist. Theclinical pathologist has the data relating to the physicalcharacteristics, and thereby makes a diagnosis of the animal health. Adrop-down menu on a computer screen provides supplemental reports tosupport the diagnosis. This can be enhanced by further input from thepathologist through keyboard entry into the computer to obtain anintegrated computer report having the laboratory analysis, supplementalreport, and selectively an enhanced report. The integrated report iselectronically communicated to a client.

A method and system of obtaining and electronically delivering anassessment of the thyroid function of an animal is achieved through acombination of computerized data and human interpretation related to theanimal. Data relating to the physical characteristics of the animal isobtained, the data being from at least one of a physical inspection ofthe animal, and the data submitted to a clinical pathologist. A blood orother body fluid sample from the animal is submitted for laboratoryanalysis of the total T4, total T3, free T4, free T3, T3 autoantibody,T4 autoantibody and thyroglobulin autoantibody.

A computer generated report of the laboratory analysis is obtained, andreported through a network, selectively an internet network, to aclinical pathologist. The clinical pathologist has the data relating tothe physical characteristics, and makes a first assessment off thethyroid function of the animal. From a drop-down menu on a computerscreen a supplemental report to support the assessment is generated.This can be selectively enhanced by a further input from the pathologistthrough data, selectively, keyboard, entry into the computer. Theassessment is dependant on animal grouping and/or on animal age. Thiscan include animal sex, performance type, size and the dependent onwhether the animal is a rural or urban area. Other factors such asanimal diet and exercise or activity level can also impact the thyroidassessment. An additional parameter which could be measured to assist inthe thyroid assessment the thyroid stimulating hormone.

An integrated computer report having the laboratory analysis,supplemental report, and selectively an enhanced report is communicatedto a remote client, such communicating being electronic.

The laboratory analytical report is reported in a first computer programand the drop down-menu is in a second computer program. The data fromthe first computer program is transferred to the second computerprogram.

The electronic communication to the client is selectively by email orfax, and wherein the second computer program includes a utility totransmit the integrated report form the second program through theutility.

The drop down menu is contained in a tool bar supplementing a wordprocessing program. The tool bar includes icons defining predeterminedsupplemental report characteristics, and selected icons may be used bythe clinical pathologist to supplement the laboratory analytical report.The icons can be grouped for animal characteristics dependant on age.Alternatively or additionally the icons are grouped for animalcharacteristics dependant on animal grouping. Alternatively oradditionally the icons are grouped for selected disease states, thestates being selectively thyroid disease, behavior, autoimmune disease,and cancer. The icons also can be grouped for selected levels ofimmunity from disease, that being the titer of immunity from the diseasein the animal, and the need for vaccination of the animal against thedisease.

Different forms of expert system computing and software programming canbe used to determine the relationship of the data bases and data.Parallel distributed processing, and neuromorphic systems, such asneural networks can be used. They are good pattern recognition enginesand robust classifiers, with the ability to generalize in makingdecisions about imprecise input data. There are multitudes of differenttypes of networks such as a multilayer perceptron which is generallytrained with the backpropagation of error algorithm, learning vectorquantization, radial basis function, Hopfield, and Kohonen. Some arefeedforward while others are recurrent (i.e., implement feedback)depending on how data is processed through the network. Some may requiretraining while others are unsupervised or self-organizing. This can beimplemented in software or in specialized hardware.

Alternatively or additionally fuzzy logic can be used due to the dynamicnature of the data applications, rules and functions. Such logic isadaptive to the changing environment. This logic and the neural networkscan be integrated in the system.

Adaptive Logic Networks technology is an effective alternative oradditional technology. The Adaptive Logic Network is neurocomputingcapable of modeling complex non-linear systems by using piece-wiselinear data. The inputs to an Adaptive Logic Network may be the datafrom large databases as described, observations recorded by a scientist,veterinarian or owner. The outputs of an Adaptive Logic Network can beused for analysis, prediction, or real-time management.

CONCLUSION

As is clear the tests above which relate to at least one of endocrinefunction, immunologic function, gastrointestinal function andnutritional analysis, metabolism, paternity, DNA fingerprinting,hemostasis and coagulation function, vaccinal antibody status, adversevaccine reaction, infectious disease, pathology, anatomic, histological,cytologic, immunohistochemical, electromicroscopy, FACS, blood typing,bone marrow analysis and immunohistochemical staining, and allergyreaction about the animal provide useful information. This is in amanner previously not obtained.

As the above demonstrates, there is a need for providing data analysisand dissemination services to a wide variety of globally-distributedremote users. There is a need for providing a system for inputting,storing and retrieving data related to animal health assessment andgenetics in a manner which permits for the effective use of thisinformation.

The system also permits for the access to the genetic and/or phenotypedata through a password and a system whereby access to the datagenerates a fee. This system permits for the access or to provide datawith regard to credit cards or the like to ensure that the fee istransmitted automatically to a banking system for the account of thedatabase when such data is accessed.

This system also provides for a situation wherein payments can be madeby credit card for requests to perform health assessment profiles andsecure genomic mapping and genetic screening information. Suchbioinformatics system can also permit for the automatic payment for suchservices and products to the banking system of the database orlaboratory. As such, the database may require that the payments beguaranteed, for instance by supplying a credit card number with arequest for performance of services and a product, and for the retrievalof such data.

A user can submit a request to the database in any number of ways. Forexample, the request can be submitted via on-line direct connection,namely through a computer network such as the Internet. An intermediateresearcher such as a veterinarian or scientist other than the ownercould also submit the request on behalf of the owner using the e-mailcapabilities of the central database system. Alternatively, the user cansubmit the data via an interactive voice response unit coupled to thedatabase system of the supplier. In some situations, the databasesupplier can decide whether to supply the health assessment informationand/or genomic mapping and genetic screening information based on thecriteria of the user or its intermediary agent. Such user orintermediary agent can be notified of the decision via the interactiveresponse unit or a live operator.

The user or agent can log into the database system and obtain thenecessary records relating to an animal physical health and/or geneticancestry or offspring. The database system can transmit in real time oron a periodic basis as determined, thereby, providing informationregarding the health assessment or the genetic background and forwardthis information to the user and/or its intermediary agent.

The data storage devices of the disclosure include a variety ofdatabases including a database relating to the phenotypic data of aparticular species, a database relating to health assessment or otherphenotypic data of particular animals in a particular species, andgenetic characteristics of different species and different family treesrelating to different species. The family trees would containinformation including the origin, genomic map, and parental lines of aspecies and records of health and performance of a species. Thesedatabases are interrelated in an analytical manner and in accordancewith different algorithms of permutations and probabilities tofacilitate useful output information based on the combination of data inthe genotypic and the phenotypic databases, and the selected databases.

The probability that an individual animal will develop a specifichealth-related condition in its lifetime is a product of complexinteractions between its genetic makeup, environmental influencesincluding diet, and agents of disease (e.g., chemical, physical, orbiological) that it encounters. Perhaps the best indicator of overallhealth of an individual animal or breed is longevity.

The genotypic information relates to genetic mapping, geneticbackground, and genetic screening databases. This includes data obtainedfrom the pedigree, family history, heritable physical characteristics,genetic screening tests, DNA testing, genomic mapping, and relatedlaboratory assessment of the gene product for known or suspectedcongenital and heritable traits. In this application, the term “geneproduct” means the specific phenotypic characteristic(s) resulting fromthe expression of the genotype, and may include certain specificlaboratory test data.

The phenotype, health profile, or health assessment database containsdata which is mostly phenotypic. The genotype database includes datawhich is in the category of mostly genotype or genetic and which mayinclude a second category of some phenotype data which predicts ormanifests the genotype and genetic data. The invention includes relatingthe phenotypic data to either one or both types of the genotypic data.

Information in the databases are used to build computer drivenstatistical models to predict the occurrence of specific diseases andlongevity for individual animals on a breed-by-breed or family and groupbasis. Multivariate statistical techniques are used including multipleregression, logistic regression, and Cox proportional hazards. As newdiagnostic technology and genomic information become available, thedatabase is continually expanded and the statistical models are updatedto enhance predictive ability. This ability to predict the occurrence ofdisease or disorder is used to develop and evaluate screening programsin veterinary medicine in order to detect disease earlier, therebyimproving the outcome and quality of life for animals and their owners.The information is also used to design disease prevention programs basedon dietary/environmental modification and selective breeding. Thedatabase is also used to explore previously unsuspected relationshipsbetween specific diseases such as cancer and diet, vaccination, orchemical exposures.

Some of the characteristics of animals with which this invention isconcerned are the following:

Genotype & Some Animal Mostly Mostly Phonotype Characteristics PhenotypeGenotype (Gene Product) Species X Purebread X Crossbred X Mixed breed XSize X Weight X Age X Sex X Lifespan X Body type X Color X Familyhistory X DNA testing X Genomic mapping X Bloodtype X Thyroid function Xvon Willebrand factor X Hemophilia X Other bleeding disorders X GlucoseX Cholesterol X Alkaline phosphatase X Alanine aminotransferase X Bileacids X Cortisol X Cataracts X Progressive retinal atrophy XMicroophthahnia X Dry eye (KCS) X Hip dysplasia X Arthritis XTemperament X Ruptured cruciate ligament X Hemolytic anemia X UrinalysisX Kidney stones X Bloat (gastric dilatation) X Pyoderma X Seborrhea XSebaceous adenitis X Umbilical hernia X Inguinal hernia X Epilepsy XHeartworm disease X Cardiomyopathy X Patent ductus arteriosus XImmunoglobulin levels X

[Many other examples of the disclosure exist, each differing from othersin matters of detail only. The disclosure is to be determined by thefollowing claims.

PRIORITY STATEMENT

This application is a divisional of application Ser. No. 12/957,118,filed Nov. 30, 2010, which is a divisional of application Ser. No.12/355,721, filed Jan. 16, 2009, now issued U.S. Pat. No. 7,865,343.This application is also a divisional of application Ser. No.10/635,707, filed Aug. 5, 2003, now issued U.S. Pat. No. 7,548,839,which is a continuation-in-part of and relates to application Ser. No.09/419,192, filed Oct. 15, 1999, now issued U.S. Pat. No. 6,730,023, andalso application Ser. No. 09/432,851, filed Nov. 2, 1999, now issuedU.S. Pat. No. 6,287,254. This application also relates to ProvisionalApplication No. 60/403,203, filed Aug. 12, 2002.

1-75. (canceled)
 76. A method for determining a nutritional diet for a canine or feline companion animal comprising the steps of: (a) receiving first data relating expression data from a genomic map of the animal and a physiological condition of the animal, and second data comprising an effect of nutrition on the expression data from the genomic map; and (b) based on the relationship of said first and second data, determining a nutritional diet for the canine or feline companion animal.
 77. A method as claimed in claim 76 wherein second data comprising the effect of nutrition on the expression of a gene in the genomic map.
 78. A method as claimed in claim 76 wherein second data comprising the effect of nutrition on the expression of genes in the genomic map.
 79. A method as claimed in claim 76 further comprising producing said nutritional diet in a diet product.
 80. A method for determining a nutritional diet for a canine or feline companion animal comprising the steps of (a) receiving first data comprising relating of gene expression in a genome of the animal and a physiological condition of the animal, and second data comprising an effect of nutrition on the expression of genes in the genome; and (b) based on the relationship of said first and second data, determining a nutritional diet for the canine or feline companion animal.
 81. The method as claimed in claim 80 including further comprising producing said nutritional diet in a diet product.
 82. The method of claim 76 wherein the animal is defined by a characteristic selected from the group consisting of breed type, specific breed, chronological age, physiological age, activity level, state of health, and state of disease or disorder.
 83. The method of claim 76 wherein the first data are derived from samples collected from a group of animals representative of a range of genotypes and physiological conditions.
 84. The method of claim 76 wherein the first data is selected from the group consisting of breed, breed(s) of parents, pedigree, sex, age, presence of hereditary conditions and disorders.
 85. The method of claim 76 wherein the first data is selected from the group consisting of age, weight, veterinary medical history, reproductive history, present health, disorder state, activity level, and temperament and presence of behavioral abnormalities.
 86. The method as claimed in claim 76 wherein the physiological condition comprises the gastrointestinal function, wherein said gastrointestinal function is assessed by at least one of serum chemistry, serum cobalamin, folate, or trypsin-like immunoreactivity (TLI).
 87. The method as claimed in claim 76 wherein the physiological function comprises immunological function, wherein said immunological function is assessed by at least one of serum electrophoresis, immunoglobulin levels, complement levels, urine electrophoresis, leukocyte markers, cytokines, monokines, or chemokine levels.
 88. The method of claim 78 wherein the animal is defined by a characteristic selected from the group consisting of breed type, specific breed, chronological age, physiological age, activity level, state of health, and state of disease or disorder.
 89. The method of claim 78 wherein the first data are derived from samples collected from a group of animals representative of a range of genotypes and physiological conditions.
 90. The method of claim 78 wherein the first data is selected from the group consisting of breed, breed(s) of parents, pedigree, sex, age, presence of hereditary conditions and disorders.
 91. The method of claim 78 wherein the first data is selected from the group consisting of age, weight, veterinary medical history, reproductive history, present health, disorder state, activity level, temperament and presence of behavioral abnormalities.
 92. The method as claimed in claim 78 wherein the physiological condition comprises the gastrointestinal function, wherein the gastrointestinal function is assessed by at least one of serum chemistry, serum cobalamin, folate, or trypsin-like immunoreactivity (TLI).
 93. The method as claimed in claim 78 wherein the physiological function comprises the immunological function, wherein said immunological function is assessed by at least one of serum electrophoresis, immunoglobulin levels, complement levels, urine electrophoresis, leukocyte markers, cytokines, monokines, or chemokine levels.
 94. The method of claim 80 wherein the animal is defined by a characteristic selected from the group consisting of breed type, specific breed, chronological age, physiological age, activity level, state of health, and state of disorder.
 95. The method of claim 80 wherein the first data are derived from samples collected from a group of animals representative of a range of genotypes and physiological conditions.
 96. The method of claim 80 wherein the first data is selected from the group consisting of breed, breed(s) of parents, pedigree, sex, age, presence of hereditary conditions and disorders.
 97. The method of claim 80 wherein the first data is selected from the group consisting of age, weight, veterinary medical history, reproductive history, present health, disorder state, activity level, and temperament and presence of behavioral abnormalities.
 98. The method as claimed in claim 80 wherein the physiological condition comprises the gastrointestinal function, wherein said gastrointestinal function is assessed by at least one of serum chemistry, serum cobalamin, folate, or trypsin-like immunoreactivity (TLI).
 99. The method as claimed in claim 80 wherein the physiological function comprises immunological function, wherein said immunological function is assessed by at least one of serum electrophoresis, immunoglobulin levels, complement levels, urine electrophoresis, leukocyte markers, cytokines, monokines, or chemokine levels. 